Stem cell legislation in South Africa | Stem cell research …

South Africa is by far the most developed African country, and owes much of its modernity and industrialization to the early influx of external European influences. Contributions from indigenous African tribes and migrants from Asia have also played an important part. This melting pot of cultures has led to making it very diverse and open to technological advancement.

The first human heart-to heart transplant was carried out in 1967. Stem cell research in Africa is really prominent in South Africa. There are stem cell banks which store cells of clients for future use. It is the only country in Africa so far with significant advances into stem cell research and its applications. South Africa has adopted the intermediate approach to stem cell research and use, where research is allowed, but has some level of restriction by the government. 79.9% of the population professed to be Christians in the 2001 national census. This huge majority largely skews parliamentary debates on controversial medical issues. South Africa is a parliamentary republic and legislations are subjected to strict parliamentary debate.

In the area of stem cell research, South Africa allows the derivation of human embryonic stem cells from excess In vitro fertilization (IVF) embryos, and also allows for the creation of human embryos for research. Speaking generally, South Africa has a ban on reproductive cloning, but not for therapeutic cloning. Stem cell facilities found serve therapeutic purposes, and all research involving human participants must be reviewed by ethics committees. The Human Tissue Act, which was amended in 1985, was the first kind of legislation concerning stem cell research or use. It makes provision for the use of tissues and gametes which are removed from living donors for medical purposes. This act also prohibited the use of the placentas fetal tissue for medical purposes. The prohibition took into account transplantation, therapeutic, diagnostic or prophylactic substances. Exceptions can be made with consent of the Minister or his nominee.The law also prohibited the genetic manipulation of gametes or zygotes outside the human body.

In 2003, the Ministry of Health passed a law which became known as the National Health Act. This law specifically spelt out the regulations which were to regulate stem cell research and utilization in South Africa. Several sections of the health act state whether tissues from dead persons can be used, at which age embryos can be obtained, and where to obtain permission.

The National Health Act (Act No. 61, 2003) stipulates that a person may not remove tissue, blood, a blood product or gametes from the body of a another living person. Section 56 states that it can be done with the written consent of the donor, and if it is done in the prescribed manner and conditions.

Such samples should not be taken from a mentally ill patients or patients whose tissues may not be replaceable by natural processes. It further states that placenta, embryonic or fetal tissue, stem cell or umbilical cord may not be used. An exception is made with stem cells derived from umbilical cord progenitor cells. Progenitor cells have limited differentiation and are highly specialized.

On reproductive cloning, the act prohibits the manipulation of genetic material (including human gametes, zygotes or embryos), or things like nuclear transfer or embryo splitting for the purpose of the reproductive cloning of a human being. The Minister however, has the right to permit therapeutic cloning using utilizing adult or umbilical cord stem cells. This therapeutic research is permitted on stem cells and zygotes less than 14 days old, if written consent is obtained from the donor. Offenders face up stiff fines and a jail term of up to five years if the law is violated.

References:

Republic of South Africa (2003). National Health Bill (B 32B-2003). Retrieved March 9, 2011 from http://www.doh.gov.za/docs/bills/b32b.pdf

Republic of South Africa (2004). National Health Act No. 61, 2003 in: Government Gazette No. 26595. Retrieved March 9, 2011 from: http://www.doh.gov.za/docs/legislation-f.html

International Consortium of Stem Cell Networks (2008). Global regulation of human embryonic stem cell research and oocyte donation. Retrieved March 9, 2011 from: http://icscn.files.wordpress.com/2008/09/global-regulation-hesc-research-oocyte-donation-sep-08.pdf

Swanepoel, Magdaleen (2006). Embryonic stem cell research and cloning: A proposed legislative framework in context of legal status and personhood. Magistic Legum dissertation submitted to the Faculty of Law, University of Pretoria. Retrieved March 9, 2011 from: http://upetd.up.ac.za/thesis/available/etd-07312007-150150/unrestricted/00dissertation.pdf

Roppen, H.J & Bishop, A.E (2004). Embryonic stem cells. In Cell Proliferation Vol 37, 1

Statistics South Africa (2003). Census 2001. Census in brief (PDF). Rep. 03.02.03 (2001) Retrieved March 9, 2011 from: http://www.statssa.gov.za/census01/html/CInBrief/CIB2001.pdf

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